A Blinded, Four-Way Crossover in Healthy Subjects to Assess EEG After Administration of Ketamine, Placebo and AZD6765 (AZD6765 EEG)

AstraZeneca

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: AZD6765; Drug: Ketamine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01130909

D2285M00008

Details and patient eligibility

About

This study will provide data to support preclinical to clinical translation by aligning preclinical and clinical efficacy assay with dose dependent changes in EEG.

Full description

A Phase I, Randomized, Double-Blind, Four-way Cross-over Study in Healthy Subjects to Assess Quantitative Electroencephalography (qEEG) parameters after the administration of ketamine, two doses of AZD6765 and Placebo

Enrollment: 36 patients

Sex: Male

Ages: 30 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI 18-30 Non-smoker for at least 4 weeks

Exclusion criteria

• Any clinically relevant acute or chronic disease
• History of substance abuse Hypersensitivity to ketamine

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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36 participants in 4 patient groups, including a placebo group

AZD6765 75 mg

Experimental group

Treatment:

Drug: AZD6765

Drug: AZD6765

AZD6765 150 mg

Experimental group

Treatment:

Drug: AZD6765

Drug: AZD6765

Ketamine 0.5 mg/kg

Active Comparator group

Treatment:

Drug: Ketamine

125 mL sterile NaCl 0.9%

Placebo Comparator group

Treatment:

Drug: Placebo